Clinical Insights: July 19, 2018

Clinical Insights: July 19, 2018

Welcome to the weekly edition of RxStrategies Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place.

New Drug Approval

SymtuzaTM (darunavir, cobicistat, emtricitabine and tenofovir alafenamide) – July 17, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) has approved SymtuzatmTM, the first and only complete, darunavir-based single-tablet regimen (STR) for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment naïve and certain virologically suppressed adults. SymtuzatmTM combines the proven high barrier to resistance of darunavir with a formulation designed for improved tolerability and the convenience of an STR. Read more.

TPOXX® (tecovirimat) –July 13, 2018 – The U.S. Food and Drug Administration approved TPOXX® (tecovirimat), the first drug with an indication for treatment of smallpox. Though the World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that smallpox could be used as a bioweapon. Read more.

Aristada InitioTM (aripiprazole lauroxil) – July 2, 2018 – Alkermes plc announced that the U.S. Food and Drug Administration (FDA) has approved Aristada InitioTM (aripiprazole lauroxil) for the initiation of Aristada® (aripiprazole lauroxil), a long-acting injectable atypical antipsychotic for the treatment of schizophrenia in adults. For the first time, Aristada InitioTM, in combination with a single 30 mg dose of oral aripiprazole, provides physicians with an alternative regimen to initiate patients onto any dose of Aristada® on day one. Read more.

QbrexzaTM (glycopyrronium) –June 29, 2018 – Dermira, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved QbrexzaTM (glycopyrronium) cloth, an anticholinergic indicated for the topical treatment of primary axillary hyperhidrosis in adult and pediatric patients nine years of age and older. Read more.

BraftoviTM (encorafenib) and Mektovi® (binimetinib) – June 27, 2018 – The Food and Drug Administration approved encorafenib and binimetinib (BRAFTOVI and MEKTOVI, Array BioPharma Inc.) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Read more.

ZemdriTM (plazomicin) –June 26, 2018 – Achaogen, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved ZemdriTM (plazomicin) for adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options. ZemdriTM is an intravenous infusion, administered once daily. Read more.

Epidiolex® (cannabidiol) –June 25, 2018 – The U.S. Food and Drug Administration approved Epidiolex® (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome. Read more.

Nocdurna® (desmopressin acetate) –June 22, 2018 – The Food and Drug Administration (FDA) has approved Nocdurna (desmopressin acetate sublingual tablets; Ferring) for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void. Read more.

New Formulation Approval

No new updates.

New Indication Approval

Kisqali® (ribociclib) – July 18, 2018 – Novartis announced a new approval for Kisqali® (ribociclib) from the U.S. Food and Drug Administration (FDA) for women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. Kisqali® is now the only CDK4/6 inhibitor indicated for use with an aromatase inhibitor for the treatment of pre-, peri- or postmenopausal women in the U.S., and also is indicated for use in combination with fulvestrant as both first- or second-line therapy in postmenopausal women. Read more.

Opdivo® (nivolumab) and Low-Dose Yervoy® (ipilimumab) – July 11, 2018 – Bristol-Myers Squibb Company announced Opdivo® (nivolumab) 3 mg/kg plus low-dose Yervoy® (ipilimumab) 1 mg/kg (injections for intravenous use) received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan. Read more.

Xtandi® (enzalutamide) – July 13, 2018 – The Food and Drug Administration approved enzalutamide (XTANDI, Astellas Pharma US, Inc.), for patients with castration-resistant prostate cancer (CRPC). This approval broadens the indicated patient population to include patients with both non-metastatic CRPC (NM-CRPC) and metastatic CRPC. Enzalutamide was previously approved for the treatment of patients with metastatic CRPC. Read more.

Xeomin® (incobotulinumtoxina) – July 3, 2018 – Merz North America announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Xeomin® (incobotulinumtoxinA) for the treatment of chronic sialorrhea, or excessive drooling, in adult patients. Xeomin® is the first and only neurotoxin with this approved indication in the U.S. Read more.

Tecentriq® (atezolizumab) and Keytruda® (pembrolizumab) – June 19, 2018 – FDA has limited the use of Tecentriq® and Keytruda® for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy. The Agency took this action on June 19, 2018, due to decreased survival associated with the use of Keytruda (pembrolizumab) or Tecentriq® (atezolizumab) as single therapy (monotherapy) compared to platinum-based chemotherapy in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1). Read more.

New Drug Recall and Safety Alerts

Valsartan Products – New Drug Recall Alert – July 13, 2018 – The U.S. Food and Drug Administration is alerting healthcare professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being recalled. Read more.

Fluoroquinolone Antibiotics – New Drug Safety Alert – July 10, 2018 – The U.S. Food and Drug Administration is requiring safety labeling changes for a class of antibiotics called fluoroquinolones to strengthen the warnings about the risks of mental health side effects and serious blood sugar disturbances and make these warnings more consistent across the labeling for all fluoroquinolones taken by mouth or given by injection. Read more.

Recall of Zofran and Entresto Packages – New Drug Recall Alert – July 5, 2018 – Novartis Pharmaceuticals Corporation (“Novartis”), in cooperation with the U.S. Consumer Product Safety Commission (“CPSC”) and Food and Drug Administration (“FDA”), is voluntarily implementing a CPSC-approved corrective action plan for the following product packages distributed in the United States. This action is not a result of any quality or safety concerns with the medications for their intended use. The blister cards in which these products are packaged are not child-resistant, posing a risk of harm if the tablets are swallowed by children. Read more.

New Generic Launch

Budesonide – extended-release (Uceris®) – July 9, 2018 – Teva Pharmaceutical Industries Ltd. announced the launch of a generic version of Uceris® (budesonide) extended-release tablets, 9 mg, in the U.S. Budesonide extended-release tablets are a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Read more.

Clinical and Pharmacy News

Specialty Drug Coverage Varies Widely Among Largest U.S. Commercial Insurers – July 18, 2018 – A recent Health Affairs study indicated that specialty drug coverage and reimbursement varies substantially across 17 of the 20 largest U.S. insurers, with only 15.9 percent of the drug coverage policies consistent across commercial health plans. Even among medications that were covered, many of the treatments had multiple restrictions in place prior to patients being able to access them. Read more.

FDA Finalizes Guidance on Labeling for Biosimilars –July 18, 2018 – The FDA has finalized its guidance on labeling of biosimilar products. The guidance pertains to prescribing information, but it does not provide specific recommendations on labeling interchangeable biosimilars. In the guidance, the agency reiterated its position that a finding of safety and effectiveness for the reference product can be relied upon to give healthcare providers the information they need to make prescribing positions. Read more.

FDA Pushes for More Prescription Drugs to Be Sold Over-The-Counter – July 17, 2018 – The Trump administration said Tuesday that it is pushing to let consumers purchase more medicines without prescriptions, saying better labeling and digital apps that let patients “self-select” drugs would expand access to cholesterol-reducing pills, opioid overdose-reversing naloxone and other drugs. Food and Drug Administration director Scott Gottlieb said new pathways to selling drugs over the counter also could save consumers time and money because they would no longer need to see a doctor before shopping. Read more.

Grappling with National Saline and Opioid Shortages –July 17, 2018 – In April, the American Society of Health-System Pharmacists (ASHP) surveyed more than 300 pharmacists from hospitals of various sizes, assessing the recovery of a preexisting small-volume parenteral (SVP) solution shortage and the impact of a current limit on injectable opioids. Findings revealed a tremendous strain on daily operations in most hospitals across the country, with associated negative impacts on patient care. Still, in the face of some of the worst drug shortages in American history, the lessons learned have paved the way to recent clinical and industry advancements that help mitigate shortages and prevent them from reoccurring. Read more.

ECRI to Revive Government Clinical Guidelines Website – July 17, 2018 – Not-for-profit organization ECRI Institute announced Tuesday that it will re-open a website the federal government recently shuttered, which provided access to medical practice guidelines. The National Guideline Clearinghouse website went dark Monday but will return in September under ECRI’s supervision carrying the same information. Read more.

Does Evidence-Based Medicine Adversely Affect Clinical Judgment? –July 16, 2018 – The process of generation of ‘evidence’ has an element of chance built into it. The problem of reproducibility of results is well known across the scientific disciplines, including medicine (Baker 2016). At the heart of the problem lies the ‘chaotic’ ways in which nature operates (Goodwin 1997). The deeper you look into any system, the harder it becomes to predict. Read more.

Understanding Data Aggregation in The Pharmacy Industry – July 13, 2018 – An increasing number of industries are turning to data aggregation and analysis to improve their operations. Data aggregation services are an investment that pays for themselves over time, with the increased efficiency and safety and improved customer service they bring. The pharmacy industry is just one of many economic sectors that are discovering the power of analytics. Read on to learn some of the applications pharmacies and manufacturers are finding for data aggregation. Read more.

CMS Proposes Drug Pricing, Price Transparency Changes for Medicare –July 13, 2018 – CMS has proposed a series of policy changes for Medicare that would promote prescription drug affordability within Medicare, and has also requested stakeholder comments about ways to improve price transparency for Medicare services. As part of changes to the 2019 Medicare Physician Fee Schedule (PFS), CMS would adopt a new pricing model for Medicare Part B drugs so that the prices patients pay for prescription drugs accurately reflect the true cost. The new drug purchasing model aims to reduce out-of-pocket spending for senior citizens. Read more.

HHS Eliminates 20 Years of Evidence-Based Medical Guidelines – July 12, 2018 – The federal government eliminated nearly 20 years of medical guidelines accumulated and curated by the Agency for Healthcare Research and Quality. AHRQ web pages for the National Guideline Clearinghouse and the National Quality Measures Clearinghouse featured announcements stating they would go dark on July 16, 2018. Read more.

Do You Need Blood Pressure Treatment? Millions More Americans Will Now Need Drugs, According to New Guidelines –July 12, 2018 – New guidelines for high blood pressure would significantly increase the number of people who are labeled as having high blood pressure, according to a study published in The BMJ. The American College of Cardiology and the American Heart Association recently released guidelines that lowered the values used to define high blood pressure, or hypertension, and the threshold at which treatments would be recommended. Read more.

Physician Fee Schedule: CMS To Trim Part B Add-On for New Drugs –July 12, 2018 – The Centers for Medicare & Medicaid Services announced a series of proposed changes Thursday to Medicare’s physician fee schedule for 2019 promising, among other things, to advance the Trump administration’s commitment to lowering prescription drug prices. Read more.

It’s Generics Not PBMs That Keep Pharmaceuticals Affordable –July 12, 2018 – Expenditures on prescription drugs grew 12.4 percent in 2014 and 8.9 percent in 2015. These eye-popping data are not representative of the long-term expenditure trend, however. Not only did the growth in prescription drugs expenditures slow to 1.3 percent in 2016, longer-term (between 2009 and 2016), the average annual growth in pharmaceutical expenditures was 3.8 percent while the average annual growth in healthcare expenditure was a faster 4.2 percent. Read more.

How a Human Pharmacist Could Outperform Amazon’s PillPack – July 12, 2018 – I am familiar with the Pill Pack model, but I saw it presented along with a robotic dispensing device that “watches” the patient take their meds for adherence purposes. This was geared to an elderly population that needed closer follow-up. The elderly are actually a population that I think could really benefit from this service. They are typically home-bound, on a lot of various meds/OTCs, and need assistance to sort and manage them to ensure they are taking them properly. Read more.

Policymakers Seek Ways to Lower Drug Costs at the Pharmacy Counter – July 12, 2018 – Federal and state lawmakers continue to search for ways to lower the burden of high prescription drug prices on patients. Some are targeting what are known as “gag rules” and “clawbacks”—two practices that may cause patients to overpay at the pharmacy counter. Read more.

What to Do About the Personalized Medicine Knowledge Gap –July 12, 2018 – Personalized medicine is a healthcare approach that utilizes various technologies to accurately separate patients into specific groups for more precise treatment. Genomics is a key technology being leveraged by some healthcare providers to assist in making treatment decisions. Read more.

Study: PBMs Lower Most Drug Costs for Most People, Encourage Innovation in Pharmaceutical Pricing, Production –July 11, 2018 – Skyrocketing costs for prescription drugs has put scrutiny on the role pharmacy benefit managers, or PBMs, play in negotiating pharmaceutical prices with manufacturers on behalf of insurers who provide health policies for nearly 300 million Americans. Drawing heat from the Trump Administration, Congress and state lawmakers around the nation is the opaque PBM practice of securing rebates – or clawbacks – from drug-makers and imposing rules that forbid pharmacists from discussing prescription drug prices with customers. Read more.

JC Survey Has Pharmacists Feeling the Pain – July 11, 2018 – Health systems preparing for their next visit from the Joint Commission would do well to focus on compliance in two areas: the organization’s new—albeit controversial—pain standards and the key measures required to ensure safe sterile compounding. Read more.

The Benefits of the Hub for Specialty Patients – July 10, 2018 – Picture your childhood bicycle, banana seat and all; now picture the front wheel of that bicycle. That bicycle wheel can serve as a metaphor for the holistic specialty patient experience. Around the outside of the wheel at the end of the spokes reside the patient, the physician/prescriber, the insurance provider/pharmacy benefit manager, the specialty pharmacy, and the pharmaceutical manufacturer. Read more.

Patients Can Get—And Pharmacists Can Provide—Naloxone at The Pharmacy. Why Don’t They? –July 10, 2018 – Several major chains have trained all their pharmacists on naloxone. Forty-eight states and Washington, DC, allow pharmacists to dispense naloxone without a physician’s prescription. Access to naloxone through pharmacists is a win for the pharmacy profession—the role pharmacists could play in resolving the opioid epidemic is a major plank in the argument for provider status. So why hasn’t access to naloxone at pharmacies brought more patients in to get it? And why are many pharmacists reluctant to provide it? Read more.

Is Amazon’s Purchase of Pillpack a Prescription For Disruption In The Pharmacy Industry? – July 9, 2018 – First they came for the book industry; then they came for the grocery business; next up for Amazon – pharmacies? Amazon’s planned purchase, for a rumored $1 billion, of PillPack is being closely watched as an indicator of where the retail behemoth is fixing its attention next. Read more.

An Inconvenient Truth for Independent Pharmacies –July 9, 2018 – In the world of Amazon acquisitions and the growing mail order pharmacy market, it is becoming increasingly apparent that the world is changing, including the economy, and especially the marketplace. Indeed, technology has turned everything upside down, from how we record data, to how people shop. One thing has remained constant, however, and far too many independent pharmacies have taken their eye off the ball here. Read more.

340B in the News

Rural Providers Show Support For 340b In Drug Pricing Blueprint – July 17, 2018 – Rural health providers and advocates for the 340B Drug Pricing Program issued their support for the federal 340B Drug Pricing Program by Monday, the final day for public comment on the “HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. “While the overall prescription drug pricing plan elicited more than 2,000 responses, the 340B program component generated about two dozen comments from rural health systems, disproportionate-share hospitals (DSH), and 340B Health, a leading advocate for the program on Capitol Hill. Read more.

July 2018: Where Are We Now With 340B? – July 17, 2018 – It seems like every week, there are multiple new developments in the 340B program. While it has just been a few weeks since my last 340B blog post, since that time we have had another Senate hearing, a new GAO Report, a new House hearing, and introduction of more than a dozen new bills in Congress. But why, despite all these developments, does it feels like little has actually changed in the 340B world since January? Read more.

Hospital Officials Lobby for Medication Program –July 17, 2018 – Paulding County Hospital (PCH) representatives Randy Ruge, CEO, and Barb Hoersten, VP Pharmacy and Radiology, met with elected officials in Washington, D.C. to request that lawmakers keep the medication discount program known as 340B. This program, enacted by Congress, allows certain healthcare providers serving high volumes of low-income and rural patients to access discounted drugs and use the savings to provide lifesaving care. Read more.

Guest Opinion: Drug-Pricing Program Strengthens Health Care –July 17, 2018 – Vidant Health, like hospital systems around the nation, plays a critical role as a healthcare safety net, providing high-quality care to all patients, including those who are under- or uninsured. According to the 2015 Small Area Income and Poverty Estimates, 28 of the 29 counties in the Vidant service area were estimated to have a poverty rate above 10 percent, with 14 counties above the 20 percent level. Read more.

Appeals Court Rejects Hospitals’ Challenge To 340B Cuts – July 17, 2018 – A federal appellate court on Tuesday rejected the American Hospital Association’s attempt to block HHS’ $1.6 billion in Medicare 340B reimbursement cuts. In a unanimous decision, three judges from the U.S. Court of Appeals for the District of Columbia Circuit sided with HHS and ruled the hospitals’ suit was filed prematurely since hospitals had not formally filed claims with the secretary because they were not yet experiencing cuts. Read more.

Hospitals Say 340B Should Not Be Part of Trump’s Drug Price Agenda – July 16, 2018 – Reforming the 340B program should not be undertaken as part of President Donald Trump’s effort to lower drug prices, hospital industry representatives are telling HHS. The suggestion came in comments responding to the Trump administration’s Blueprint to Lower Drug Prices released in May. Responses to the document were due July 16. Read more.

Top Changes to Watch For in the 340B Drug Discount Program – July 13, 2018 – For many providers, the 340B program – which requires pharmaceutical manufacturers to provide covered outpatient drugs to certain eligible hospitals and federal grantees at discounted prices in order to have their drugs covered under Medicaid – is a crucial source of revenue that supports much-needed and otherwise uncompensated charity care. Read more.

Some 340B Hospitals Pocket Savings Meant for Low-Income Patients, Says GAO Report – July 13, 2018 – Sixteen out of 28 hospitals the Government Accountability Office recently surveyed were not providing patients discounts at pharmacies as intended under the 340B Drug Discount Program, according to USA Today. The 340B Drug Discount Program requires pharmaceutical makers to sell discounted drugs to providers, with the hopes of lowering costs and expanding access for low-income patients. However, federal regulators said more than half of surveyed hospitals may have pocketed the savings instead. Read more.

340B: Where Are We Now After a Hectic Week? –July 13, 2018 – This week has been jam-packed full of 340B activity, but there still doesn’t seem to be a consensus on the program going forward. On Monday, the head of the Health and Human Services Department, Alex Azar, gave his two cents about the program—which largely focused on the need for transparency and oversight over the program. Read more.

GAO: Some Hospitals Pocket Savings from Program Meant to Lower Costs for Low-Income Patients – July 12, 2018 – A federal program that requires pharmaceutical manufacturers to sell discounted drugs to certain health care providers was intended to expand services and lower costs for low-income consumers. But federal investigators found some hospitals are keeping the savings. Read more.

My Turn: Tim Babineau: Drug Savings Help Needy Patients –July 11, 2018 – Lifespan’s hospitals, like many hospitals around the nation, serve a critical role as a health-care safety net, providing high-quality care to all patients, regardless of their ability to pay. We provide vital, one-of-a-kind services for our community, including a trauma center, a burn unit, cancer programs and children’s programs. Read more.

DRUG DISCOUNT PROGRAM: Improvements Needed in Federal Oversight of Compliance at 340B Contract Pharmacies –July 11, 2018 – To have their drugs covered under Medicaid, the “340B” program requires drug manufacturers to sell outpatient drugs to covered entities—certain hospitals and clinics—at a discount. These entities are increasingly contracting with pharmacies to dispense 340B drugs. Doing so can make it harder to ensure compliance with 340B rules. For example, contract pharmacies may also fill prescriptions for the general public, increasing the risk of dispensing 340B drugs to ineligible patients. We testified on our report’s recommendations to improve federal oversight of covered entities to help ensure compliance with 340B requirements. Read more.

Proposed Changes To 340B Program Would Cut DSH Eligibility by Half –July 11, 2018 – A new congressional proposal would raise the minimum disproportionate share hospital adjustment percentage that DSH hospitals must meet to qualify for the 340B drug discount program, eliminating 340B eligibility for over half the participating hospitals, according to a study by 340B Health. Read more.

AHF Condemns PhRMA’s ‘Undue Influence’ on Congress; ‘Politico’ Ads Expose Industry’s Efforts to Kneecap 340B Drug Program –July 10, 2018 – AIDS Healthcare Foundation (AHF) is once again sounding an alarm about the oversized and undue influence that the drug industry, its trade group, PhRMA (Pharmaceutical Research and Manufacturers of America), and its lobbyists have in Washington and on Congressional hearings to the detriment of both the American public and the American taxpayer. Read more.

Azar Promises a 340B Pricing Rule Will Come, Despite Delays –July 9, 2018 – HHS Secretary Alex Azar assured a provider group Monday that the agency is committed to releasing regulation involving setting drug ceiling prices for the 340B Drug Discount Program, despite many delays to implement a rule on the issue. In a speech to 340B Health, a hospital trade group, Azar said he was disappointed that providers viewed the five delays for implementing the program’s ceiling price rule as a favor to drug companies that opposed the rule. Read more.

Study: Hospitals May Not Be ‘Gobbling Up’ Physician Practices –July 9, 2018 – A new study challenges the idea that hospitals are “gobbling up” physician practices. While many hospitals are acquiring physician practices, it’s rarely en masse, according to a study published this week in Health Affairs. On average, hospitals acquired only one or two practices between 2007 and 2017, the study said. Acquisition rates varied widely between specialties: More than 51 percent of oncology practices that were independent in 2007 had been purchased by a hospital or health system by 2017 compared to just under 10 percent of ophthalmology practices. Read more.

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"Due to RxStrategies' comprehensive solutions specifically for FQHCs to manage a compliant 340B program, our available discounts from the 340B program tripled in the rural areas where we operate in partnership with contract pharmacies."

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